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INDIA REACH Compliance

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India is currently drawing up the fifth version of its Draft Chemicals (Management and Safety) Rules, (“India REACH”), which is expected to be the final one. It will be published later this year for wider industry consultation.

“India REACH” is expected to be published and enforced in early 2021. There have been delays to the proposed rules as a result of the ongoing Covid-19 pandemic.

As planned, it will be notified to the WTO this year and come into force on the date when it is published in the Official Gazette.

The Rules apply to “all substances, substances in mixtures and intermediates that are manufactured, imported, placed or intended to be placed in Indian Territory”. It requires manufacturers, importers, or Authorized Representatives (designated on behalf of the foreign manufacturer, similar to “Only Representative” under EU REACH) to notify new and existing substances and register substances that need registration. Restriction or prohibition of uses of certain substances may be required if they are evaluated and found to pose unacceptable risks to human health and the environment.

According to the draft regulation

  • The Chemical Regulatory Division (CRD) will be established as the competent authority for chemical management in India.

  • Foreign manufacturers will need to appoint an India-based Authorized Representative (AR) to fulfill legal obligations. The AR’s function is similar to the Only Representatives in EU REACH.

  • Joint registration will be accepted but detailed rules on data sharing etc. have not yet been published.

  • Notification will be required within 180 days from the date of enforcement of the regulations. This requirement applies to all existing substances manufactured and imported at a volume above 1 tonne per year. The substance will be notified for certain uses and downstream users need to notify CRD if the intended use is not notified.

  • Notification of new chemicals is required before entering the Indian market.

  • Companies will be required to register Schedule VI listed substances over 1 t/y and will need to follow the requirements set out in Schedule VII. Chemical Safety Reports (CSR) are required for these substances over 10t/y.

  • The CRD will evaluate all substances and list the priority substances in Schedule II. This list will be assessed further to see if which substances require restriction or authorization.

  • Companies handling priority and hazardous chemicals are subjected to further regulatory requirements (e.g. chemical safety report, exposure scenarios, restriction, prohibition).

Exemptions

The Rules does not apply to substances that fall under one of the following items

  • Radioactive substances

  • Substances under the customs supervision, not being placed in Indian Territory

  • Substances stored in customs-free zones with aim of re-exporting

  • Wastes, as defined in Hazardous Waste Management Rules 2016

  • Substances used for defense purposes

  • Substances used as food or feeding stuff for human beings or animals, including human or animal nutrition

  • Substances set out in Schedule IV

Services from APA

  • 1India REACH Authorized Representation

  • 2Development of notification, registration strategies

  • 3Global chemical Notification consultation

  • 4Classification and labeling of the substance